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Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00193037
First Posted: September 19, 2005
Last Update Posted: July 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ortho Biotech, Inc.
Aventis Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
  Purpose
The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.

Condition Intervention Phase
Breast Cancer Drug: Liposomal Doxorubicin Drug: Docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 Months ]
    ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.


Secondary Outcome Measures:
  • Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. [ Time Frame: 18 Months ]
    PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.


Enrollment: 102
Study Start Date: February 2001
Study Completion Date: November 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liposomal Doxorubicin
Liposomal doxorubicin 40 mg/m2 by 1 hour IV infusion repeated every 28 days.
Drug: Liposomal Doxorubicin
Liposomal Doxorubicin
Other Name: Doxil
Experimental: Docetaxel
Weekly docetaxel 36 mg/m2 by 30 minute IV infusion on days 1, 8, and 15 of the 28 day cycle
Drug: Docetaxel
Docetaxel
Other Name: Taxotere

Detailed Description:

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

  • Liposomal Doxorubicin
  • Docetaxel

For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM, provided patient still meets the eligibility laboratory and performance status criteria. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Metastatic breast cancer confirmed by biopsy
  • Prior adjuvant/neoadjuvant treatment allowed
  • Measurable disease
  • Able to perform activities of daily living with minimal assistance
  • Age 18 years or older
  • Adequate bone marrow, liver and kidney function
  • Normal heart function
  • Written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Pre-existing moderate peripheral neuropathy
  • History of significant heart disease
  • Meningeal metastases.
  • Prior chemotherapy for metastatic breast cancer
  • No measurable disease (including bone only, pleural effusions, etc.)
  • Receiving Herceptin therapy.
  • Women who are pregnant or lactating.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193037


Locations
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
SCRI Development Innovations, LLC
Ortho Biotech, Inc.
Aventis Pharmaceuticals
Investigators
Principal Investigator: Denise A. Yardley, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193037     History of Changes
Other Study ID Numbers: SCRI BRE 43
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: August 22, 2012
Results First Posted: July 19, 2013
Last Update Posted: July 31, 2013
Last Verified: July 2013

Keywords provided by SCRI Development Innovations, LLC:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Liposomal doxorubicin
Doxorubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors